CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
18 Years
65 Years
Both
Cardiac Transplantation, Skin Cancer
Trial Information
CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
- Open labelled randomized Everolimus vs reduction of calcineurin inhibitors trial. 2:1
randomization design
- October 10, 2008
- 159 patients (106 everolimus vs 53 calcineurin inhibitors reduction)
- 175 patients (117 vs 58)
- X Not yet recruiting 0 recruiting 0 no longer recruiting
- Number of skin tumors per patients requiring surgery with histology control within 2
years
Within 2 years of Follow up:
- New skin cancer
- Number of patients with new skin cancers
- Time of recurrence
- Number and histology of other types of skin cancer
- Graft function (including acute rejection, graft loss, death)
- Renal function evolution as assessed using cockroft creatinine clearance and
proteinuria
- Adverse events and serious adverse events
- Non skin cancer (Number and diagnostic)
- Schemes of calcineurin inhibitors reduction/withdrawal
- Immune response assessment through regulatory or effector function of blood and in situ
T lymphocytes at baseline and following immusuppression switch
Inclusion Criteria:
- First orthotopic heart transplant after 1st year
- No rejection within previous 6 Months
- Occurrence within the three previous years of squamous cell carcinoma, basal cell
carcinoma, in situ carcinoma, Bowen disease, premalignant keratosis.
- Recurrence of skin cancers leading to immunosuppressive regimen modifications
- Above 18 yrs and under contraceptive drugs if applicable
- Informed consent given
- Health coverage ongoing
Exclusion Criteria:
- Other non simultaneously transplanted organ
- recent biopsy proven acute rejection
- Proteinuria > 1g/l
- Ongoing infectious disease
- HIV positivity, Chronic active Hepatitis B or C.
- Abnormal blood tests: transaminases >= 3UNL, Bilirubine > 34 mmol.l, albumin<35 g/l,
spontaneous INR >1,3
- Hemoglobin >= 8 g/dl, White Blood Count<= 2 giga/l, platelet count <= 50 giga/l
- Hypercholesterolemia>= 9 mmol/l, hypertriglyceridemia >= 8,5 mmol/l despite treatment
- History of macrolid or mTor inhibitor intolerance
- Previous cancer other than skin within last 5 years
- Medical or surgical condition unsuitable for the trial
- Breast feeding
- Positive pregnancy test
- Severe psychiatric disorder
- Communication or language disability
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of skin tumors per patients requiring surgery with histology control within 2 years
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
LAURENT SEBBAG, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2007.489/32
NCT ID:
NCT00799188
Start Date:
October 2008
Completion Date:
Related Keywords:
- Cardiac Transplantation
- Skin Cancer
- Cardiac Transplantation
- Skin cancer
- Everolimus
- Skin Neoplasms
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